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Efficacy Of Bupropion For Attention Deficit Hyperactivity Disorder (ADHD) In Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Timothy Wilens, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01270555
First received: January 3, 2011
Last updated: March 4, 2013
Last verified: March 2013
Results First Received: January 7, 2011  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Substance Use Disorder (SUD)
Intervention: Drug: Bupropion SR

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Bupropion Once daily treatment with Bupropion with intention to treat ADHD and SUD.

Participant Flow:   Overall Study
    Bupropion
STARTED   32 
COMPLETED   19 
NOT COMPLETED   13 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Bupropion Once daily treatment with Bupropion with intention to treat ADHD and SUD.

Baseline Measures
   Bupropion 
Overall Participants Analyzed 
[Units: Participants]
 32 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   32 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 32  (8.5) 
Gender 
[Units: Participants]
 
Female   6 
Male   26 
Region of Enrollment 
[Units: Participants]
 
United States   32 
DSM-IV Attention Deficit Hyperactivity Rating Scale (ADHD RS) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 34.1  (8.2) 
[1] Assesses 18 individual criteria symptoms on a severity grid (0=not present, 3=severe; overall minimum score = 0, maximum score = 54)
Self-reported Weekly substance use [1] 
[Units: Participants]
 32 
[1] Participants who self-report using at least one of illegal drugs or alcohol, at least once per week.
Clinical Global Impressions (CGI) Score for SUD Severity [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 4.0  (0.9) 
[1] Global Severity 1=not ill, 7=extremely ill
Clinical Global Impressions (CGI) Score for ADHD Severity [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 5.0  (0.7) 
[1] Global Severity 1=not ill, 7=extremely ill
Hamilton Anxiety Rating Scale (HAM-A) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 8.1  (6.5) 
[1] minimum (least severe anxiety) = 0, maximum (most severe) = 56
Hamilton Depression rating Scale (HAM-D) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 8.8  (9.1) 
[1] minimum (least severe depression) = 0, maximum (most severe) = 84
Beck Depression Inventory (BDI) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 8.9  (5.9) 
[1] minimum (least severe depression) = 0, maximum (most severe) = 63


  Outcome Measures
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1.  Primary:   Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) Score   [ Time Frame: baseline and six weeks ]

2.  Primary:   Self-reported Weekly Substance Use   [ Time Frame: baseline and six weeks ]

3.  Secondary:   Clinical Global Impressions (CGI) Scale of Substance Use Disorder (SUD) Severity   [ Time Frame: baseline and six weeks ]

4.  Secondary:   Clinical Global Impressions (CGI) Scale of ADHD Severity   [ Time Frame: baseline and six weeks ]

5.  Secondary:   Hamilton Anxiety Scale (HAM-A)   [ Time Frame: baseline and six weeks ]

6.  Secondary:   Hamilton Depression Scale (HAM-D)   [ Time Frame: baseline and six weeks ]

7.  Secondary:   Beck Depression Inventory (BDI)   [ Time Frame: baseline and six weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Timothy Wilens, MD
Organization: Massachusetts General Hospital
phone: 617-503-1053
e-mail: twilens@partners.org



Responsible Party: Timothy Wilens, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01270555     History of Changes
Obsolete Identifiers: NCT01012024
Other Study ID Numbers: 1999-P-009198
Study First Received: January 3, 2011
Results First Received: January 7, 2011
Last Updated: March 4, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board